# K222224: SurgiLance® Safety Lancet

- Pathway: 510(k) (Traditional)
- Applicant: Medipurpose Pte., Ltd.
- Decided: Sep 22, 2022 after 59 days
- Product code: FMK (Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature)
- Device class: 2
- Regulation: 21 CFR 878.4850
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K822209 (1982). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101145: Surgilance Safety Lancets, Models SLN100, SLN200, SLN240, SLN300, SLB200, SLB250, Medipurpose Pte., Ltd. (2010) Summary page 4.
- K822209: Autolancet, Bd Becton Dickinson Vacutainer Systems Preanalytic (1982) Summary page 4.

## Indications for use
The SurgiLance® Safety Lancet is a puncture device to obtain micro blood samples. The SurgiLance® Safety Lancet has a sharps prevention feature to protect the user from a needlestick injury. Single patient use only.

Source page: https://510kreport.com/device/K222224
Methodology: https://510kreport.com/methodology